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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00114582
Other study ID # 2420.0021
Secondary ID
Status Completed
Phase Phase 2
First received June 15, 2005
Last updated February 12, 2009
Start date April 2002
Est. completion date December 2003

Study information

Verified date February 2009
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance.


Description:

Study design: During six months the intervention group had their meals in family style, and the control group received the usual tray services.

Hypothesis: We hypothesized that the intervention program had a positive effect on quality of life, food intake, body weight, physical performance, and biochemical data (hematocrit, hemoglobin, leucocytes, ferretin, albumin, homocysteine and folate) among the residents in the intervention group, while these outcome measures would regularly decline among the residents in the control group.

Site and participants: Nursing homes volunteered to participate in the study. In each nursing home there was a control and intervention ward. Only residents with a chronic somatic disorder were included. Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition. The ethical committee and the client board of the nursing homes and the medical ethical committee of Wageningen University approved the study protocol.

Intervention: The intervention program lasted for six months and was based on an inventory research of mealtime ambiance models in the Netherlands. The program consisted of five aspects: table dressing, food services, staff protocol, residents' protocol, and mealtime protocol. Before the start of the meal, tables were set with tablecloths, full cutlery and plates. The cooked meal was served in dishes and residents had the opportunity to choose between two kinds of vegetables, two kinds of meat and potatoes.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Nursing home residents with a chronic somatic disease and long term care

Exclusion Criteria:

- Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
family style dinner


Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Wageningen University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Mathey MF, Vanneste VG, de Graaf C, de Groot LC, van Staveren WA. Health effect of improved meal ambiance in a Dutch nursing home: a 1-year intervention study. Prev Med. 2001 May;32(5):416-23. — View Citation

Nijs K, Vanneste V, de Graaf K, van Staveren W. [Project models to improve the ambiance during meal times in Dutch nursing homes: incentives and barriers for implementation]. Tijdschr Gerontol Geriatr. 2003 Dec;34(6):246-53. Dutch. — View Citation

Nijs KA, de Graaf C, Kok FJ, van Staveren WA. Effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents: cluster randomised controlled trial. BMJ. 2006 May 20;332(7551):1180-4. Epub 2006 May 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Nutritional status
Primary Quality of life
Primary Physical performance
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